Bio Pharma | Vaccines | Sterile Formulations

Our sterile systems are designed to be 100% cleanable and are free from dead-leg areas. To ensure that our products offer consistent quality, we use high precision components integrated with a fully automated and intelligent control system and a full cGMP documentation package.

Features

Codes and Standards

cGMP / FDA

Designed as per ASME / PED

Manufactured in compliance with ASME BPE or cleanability&sterilisation

On completion of the Factory Acceptance Test (FAT), the equipments, components, instruments, etc. are packed in transport worthy packing and items are duly labelled for easy identification at site.

DDE’s site team is mobilized to ensure efficient and least instructive installations, which would involve the following activities:

Verification during unpacking for ensuring no damages in transit

All parts i.e. equipments, components, instruments etc. are verified with packing list in order to ensure no shortages

Supervision of installation of the system at the desired locations

The pipelines etc. are connected and the instruments are fixed to the systems, as per P & ID and 3D Layouts, which forms a part of Design Qualification Documents (DQ)

The Site Acceptance Test (SAT) “Pre- checklist” is verified for the following typical checks, thereafter to be handed over for Qualification:

The electrical & system communication connectors are in line with the “Electrical Architecture” & “System Architecture”

All required utilities are available

All required solutions / instruments are available for conducting the SAT Qualification

The SAT Installation Qualification (IQ) & Operational Qualification (OQ) protocols have been signed off by the concerned departments.

Qualification

Commissioning & Qualification

Our experienced Commissioning and Qualification team have the technical skills required to ensure successful handing over to the customer for initiating process qualification activities.

A well planned documented and managed engineering approach is used, that results in a safe and functional environment that meets established design requirements and stakeholder’s expectations.

Qualification is usually carried out by conducting the following actives, individually or combined.

Design Qualification (DQ)

Documented verification that the proposed design of the equipment or systems is suitable for the end use

The tests and verification required to be undertaken during commissioning is documented in “Equipment Qualification Plan” (EQP), which is approved by the end user prior to commission with IQ & OQ qualification activities. EQP would indicate the verification and tests to be carried out during SAT IQ & OQ.

Installation Qualification (IQ)

Documented verification that the equipment or systems are installed or modified.

Operational Qualification (OQ)

Documented verification that the equipment or systems, perform as intended throughout the anticipated operating ranges (An interactive SOP, comes with the IQ/OQ protocol and on completing the requirements specified in the SOP, the IQ / OQ protocol is completed).